Impact Model 753

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K931473 ↗

FDA Product Code

BTL

Device Class

Class II

Regulation

21 CFR Part 868.5925

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Impact, Models 306/307

  Class II

  FDA 510(k) K820338 Active Cleared 2 Mar 1982

• Impact Model E-12

  Class II

  FDA 510(k) K820330 Active Cleared 23 Feb 1982

• Impact Model 308

  Class II

  FDA 510(k) K841538 Active Cleared 11 Jun 1984

• Impact 901 Series Port-a-Wall

  Class I

  FDA 510(k) K850671 Active Cleared 11 Mar 1985

• Impact, Universal Single-Limb, Ventilator Circuit, Model 820-0099-00

  Class II

  FDA 510(k) K022062 Active Cleared 6 May 2003

• Impact Model 601

  Class II

  FDA 510(k) K841537 Active Cleared 31 May 1984

See all devices from Impact Instrumentation, Inc. →

• What is the Impact Model 753 used for?

  The Impact Model 753 is a powered emergency ventilator intended to provide emergency respiratory support via face mask or endotracheal tube in emergency settings, as it delivers ventilatory assistance when spontaneous breathing is inadequate or absent.

• How is the Impact Model 753 supplied and is it reusable?

  The Impact Model 753 is supplied non-sterile and is intended for reusable use, meaning it can be cleaned and reprocessed between uses according to the manufacturer's instructions for emergency respiratory support applications.

• What regulatory pathway was used for the Impact Model 753?

  The Impact Model 753 received FDA 510(k) clearance through the traditional process under K number K931473, demonstrating substantial equivalence to a predicate device for its intended use as a powered emergency ventilator.